Transcranial Magnetic Stimulation (TMS) The treatment coil produces MRI-strength magnetic field pulses. Magnetic field pulses pass unimpeded through the cranium for 2-3 cm. and induce a small electric current. Induced electric currents stimulate the firing of nearby neurons, causing the release of neurotransmitters and clinical effects. Faraday (1839) Experimental Research in Electricity. Vol 1; Barker (1991) J Clin Neurophysiol; Barker (1985) Lancet 1
Notable Institutions Providing NeuroStar TMS Therapy Johns Hopkins Hospital, Baltimore McLean Hospital, Belmont, Mass. The Resnick Neuropsychiatric Hospital at UCLA, Los Angeles Sheppard and Enoch Pratt Hospital, Baltimore Mayo Clinic, Rochester, Minn. Butler Hospital/Brown University Stanford Hospital Rush University Medical Center BIDMC/Harvard University Loma Linda University Boston University University of Texas, Southwestern Walter Reed Army Medical Center Weill Cornell Medical College University of Michigan Medical University of South Carolina University of Cincinnati/LCOH University of Florida University of South Florida Henry Ford Health Care System Southern Illinois University University of Connecticut Northwestern University Marshall University Tripler Army Medical Center Sibley Memorial Hospital 2
NeuroStar TMS Therapy: Safety Overview No systemic side effects No adverse effect on cognition Most common adverse event associated with treatment was scalp pain or discomfort < 5% of patients discontinued due to adverse events No seizures during clinical studies (over 10,000 treatments) Estimated risk of seizure in post-market use is 0.003% of TMS treatments and 0.1% of patients (based on 100,000 TMS treatments and 3000 patients) Long term safety demonstrated in 6 months follow-up Janicak, P., J. P. O'Reardon, et al. (2008). "Transcranial Magnetic Stimulation in the Treatment of Major Depressive Disorder: A Comprehensive Summary of Safety Experience from Acute Exposure, Extended Exposure, and During Reintroduction Treatment." Journal of Clinical Psychiatry 69(2): 222 232.; Janicak, P. G., Z. Nahas, et al. (2010). "Durability of clinical benefit with transcranial magnetic stimulation (TMS) in the treatment of pharmacoresistant major depression: assessment of relapse during a 6-month,multisite, open-label study." Brain Stimulation 3(4): 187-199. 3
NeuroStar TMS Therapy: A Well-Tolerated Antidepressant (Adverse Events with incidence > 5% and 2x control) Systemic Drug Side Effects Weight Gain Constipation Diarrhea Nausea Fatigue Headache/ Migraine Abnormal Ejaculation NeuroStar TMS Side Effects Application site pain or discomfort Drowsiness Insomnia Decreased Libido Nervous Anxiety Increased Appetite Decreased Appetite Impotence Sweating Tremor Treatment Discontinuation Side Effects Weakness Dry Mouth Dizziness Product prescribing information for marketed classes of antidepressant medications [SSRIs, SNRIs, MAOIs, TCAs, SGAs] (2011): [list all medications reported in table above]; NeuroStar TMS Therapy User Manual (2011) and data on file. 4
Best Practices Treatment Guideline for Depression Based on 2010 APA guidelines and NeuroStar TMS Therapy indication for use. Adapted from: Practice Guideline for the Treatment of Patients with Major Depressive Disorder, 3 rd Edition, APA (2010) 5
TMS is a New Standard of Care for Depression Following Failure of Initial Treatment Guideline Source Recommendations American Psychiatric Association (2010) World Federation of Societies for Biological Psychiatry (2009) Canadian Network for Mood and Anxiety Treatments (2009) Institute for Clinical Systems Improvement (2010) Acute phase treatment may include pharmacotherapy, depression-focused psychotherapy, the combination of medications and psychotherapy, or other somatic therapies such as electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), or light therapy There is sufficient class I evidence of acute efficacy for TMS in depression in medication-free unipolar depressed patients... Summary Recommendation: There is sufficient Level I evidence of the acute antidepressant efficacy of TMS in the treatment of depression At this time it appears there probably is enough evidence to consider rtms (as implemented with a protocol that utilizes a six-week standardized protocol) an evidence-based treatment for treatment-resistant depression in adults Schlaepfer, et al. World J Biol Psychiatry (2009); Kennedy, et al J Aff Disorders (2009); Institute for Clinical Systems Improvement (2010); American Psychiatric Association (2010) 6
Implications of Inadequate Response to MDD Treatment Increased patient care Inpatient hospitalizations, outpatient office visits, and psychotropic medications. 1,2,3 Increased annual costs Average annual costs 2-6 times greater compared to treatment-responsive patients 1,3 Increased work loss costs Significantly greater disability and absenteeism related costs than treatmentresponsive patients 1 Increased costs due to co-morbid care increased medical direct costs of non-remitters include increased medical utilization for non-psychiatric conditions 1,2 1. Corey-Lisle PK, Birnbaum H, Greenberg P, Claxton AJ. (2002) Identification of Claims Data "Signature" and Economic Consequences for Treatment-Resistant Depression. Journal of Clinical Psychiatry, 63 (8), 717-726. 2. Corey-Lisle PK, Farinpour R, Starr SR. Validation of a treatment algorithm for treatment-resistant depression. American Psychiatric Association, Philadelphia, PA. April 2002. 3. Crown, WH, Finkelstein, S, Berndt, ER, Ling D, Poret, AW, Rush AJ, Russell, JM (2002). The impact of treatment-resistant depression on healthcare utilization and costs. Journal of Clinical Psychiatry, 63 (11), 963-971. 7
CPT Category I Codes Effective January 1, 2011 90867 Therapeutic repetitive transcranial magnetic stimulation treatment; planning Report only once per course of treatment Do not report 90867 in conjunction with 95928, 95929 90868 Therapeutic repetitive transcranial magnetic stimulation treatment; delivery and management, per session Source: Current Procedural Terminology 2011, American Medical Association CPT is a Registered trademark of the American Medical Association 8
Optimization of TMS ( OPT-TMS ) Study an independent, NIMH-funded study Major Findings: NIMH-funded, independent of industry N=190 patients, 4 premier academic sites Primary outcome measure met: % Remission - Active 15% vs Sham 4% (P = 0.015); Odds Ratio of achieving remission: 4.2 (95% CI, 1.3-13.2) indicates clinical significance Safety confirmed, nearly 90% of patients adherent to acute phase treatment course Conclusion: Daily left prefrontal rtms as monotherapy produced statistically significant and clinically meaningful antidepressant therapeutic effects greater than sham. 9
What Does This Mean? Two large, multisite, randomized controlled trials confirmed the clinical significance of TMS as an antidepressant The treatment benefit of TMS over control condition (effect size) compares favorably to those seen with antidepressant medications NeuroStar TMS Therapy is a safe and effective treatment for depression patients who have not benefitted from initial antidepressant medication 10
NeuroStar TMS Therapy Clinical Evidence NeuroStar TMS Therapy is an effective, proven approach for major depression when initial treatment fails NeuroStar TMS is now incorporated into expert Practice Guidelines for use following initial treatment failure in patients with major depression NeuroStar TMS is a valuable treatment approach for use in patients who want to reduce medications and the side effect burden that goes along with them 11